A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
• Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
• Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
• Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation
• Life expectancy of \> 6 months
• Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
Locations
United States
California
Los Angeles Cancer Network
RECRUITING
Los Angeles
New Jersey
Astera Cancer Care East Brunswick
RECRUITING
East Brunswick
Other Locations
Belgium
Cliniques Universitaires St-Luc
RECRUITING
Brussels
Jessa Zkh (Campus Virga Jesse)
RECRUITING
Hasselt
UZ Leuven Gasthuisberg
RECRUITING
Leuven
Spain
Hospital Universitari Vall d'Hebron;Oncology
RECRUITING
Barcelona
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Turkey
Adana Baskent University Hospital
RECRUITING
Adana
Memorial Ankara Hastanesi
RECRUITING
Ankara
Bagcilar Medipol Mega Universitesi Hastanesi
RECRUITING
Bağcılar
Medical Park Seyhan Hospital
RECRUITING
Seyhan
United Kingdom
Blackpool Victoria Hospital
RECRUITING
Blackpool
Princess Alexandra Hospital
RECRUITING
Harlow
Mount Vernon Cancer Centre
RECRUITING
Northwood, Middlesex
Contact Information
Primary
Reference Study ID Number: WO46063 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date:2026-02-18
Estimated Completion Date:2031-10-31
Participants
Target number of participants:80
Treatments
Experimental: Inavolisib Dose A plus Fulvestrant
Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.
Experimental: Inavolisib Dose B plus Fulvestrant
Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.